Regulation of Promotion of Prescription Drugs Thomas W. Abrams, R.Ph., MBA Division of Drug Marketing, Advertising, and Communications Food and Drug Administration.

Slides:

Advertisements

Similar presentations

Direct-to-Consumer Advertising of Genetic Tests

Advertisements

An Overview of Direct-to-Consumer Prescription Drug Promotion Nancy M. Ostrove, Ph.D. Risk Communication Advisory Committee May 15, 2008.

From POM to P From POM to P Wellard’s NHS training wellards.co.uk 2004.

Neel Bhalala (2009) Sofia Medical University. Background  Erythropoiesis-stimulating agents are man-made versions of a natural protein known as erythropoietin.

@ PMCQ U October 19, Agenda l What is Advertising? l Pre-Launch Activities You Can Do l PAAB pre-NOC Meeting/Review policy.

FDA REGULATION: EFFECT ON PAIN MANAGEMENT IN THE ED RICHARD R. ABOOD, R.Ph., J.D. Professor Pharmacy Practice University of the Pacific RICHARD R. ABOOD,

UNITED SPINAL ASSOCIATION AUGUST, 2014 Biologics & Biosimilars: An Overview 1.

The Role of Risk Information in Product Labeling Catherine Gray, PharmD Management Advisor Division of Drug Marketing, Advertising, and Communications.

Project IMPACT IMPACT National Medical Association What African Americans Should Know About Clinical Trials You’ve Got the Power!

RAC Study Group Chapter 16

News You Can Use… Pete Koval, PharmD Laura Evington, PharmD candidate Cone Health Family Medicine November 2014.

Objectives Why we need DHCPL Situations that call for a DHCPL Definitions DHCPL itself–content, presentation, process Target audience Current and future.

1 Alvimopan RiskMAP Joyce Weaver, Pharm.D., BCPS Office of Surveillance and Epidemiology.

Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and.

Direct-to-Consumer Prescription Drug Promotion Nancy M. Ostrove, Ph.D. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration.

Division of Drug Marketing, Advertising, and Communications Enforcement Webinar Sangeeta Vaswani Chatterjee, Regulatory Counsel Team Leader Marissa Chaet.

 Pharmacovigilance – Patient’s standpoint Steve Arlington May 2007.

Regulation of Drug Marketing Introduction to Drug Law and Regulation FDLI Workshop April 28-29, 2003 Teaneck, New Jersey Philip Katz Crowell & Moring LLP.

An Update on NSAID Labeling and Data Review DSaRM Advisory Committee February 10, 2006 Sharon Hertz, M.D. Deputy Director Division of Anesthesia, Analgesia,

Canada Consumer Product Safety Act An Overview Graham Stewart Health Canada.

Wilson Disease Treatment Failures?

Pharmacoeconomics & Drug Compliance Dr Arif Hashmi.

Choose the disease to cure: Diabetes Lung cancer Arthritis Alzheimer’s disease Coronary artery disease (heart disease) Obesity Asthma.

1 Just The Facts Ma’am Dementia Care & Anti-Psychotics Just The Facts Ma’am December 17, 2012 Ronald A. Savrin, MD, MBA, FACS Medical Director, Ohio KePRO.

“Shocking Psychiatrics” Examining Electroconvulsive Therapy

MCA Risk:benefit analysis of Kava-kava Update as at 12 Feb 2002.

Reproductive Health Drugs, Pregnancy Labeling Subcommittee Meeting March 28-29, 2000 Holli A. Hamilton, M.D., M.P.H. Pregnancy Labeling Team Office of.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

 1. A care plan is developed for each of the patient's medical conditions being managed with pharmacotherapy.  2. A goal of therapy is the desired response.

National Survey on Consumer Reaction to DTC Advertising of Prescription Medicines: Comments from DDMAC Kathryn J. Aikin, Ph.D. Division of Drug Marketing,

Regulatory History of Sibutramine Eric Colman, MD Division of Metabolism and Endocrinology Products CDER - FDA.

1 PhRMA Guiding Principles - DTC About Prescription Medicines.

Cardiovascular Risk and NSAIDs Arthritis Advisory Committee Meeting November 29, 2006 Sharon Hertz, M.D. Deputy Director Division of Analgesia, Anesthesia,

FDA Regulation of Prescription Drug Promotion Thomas W. Abrams, R.Ph., MBA Division of Drug Marketing, Advertising, and Communications Food and Drug Administration.

THE FDA REGULATORY AND COMPLIANCE SYMPOSIUM Managing Risks – From Pipeline to Patient Presented by: Steven A. Johnson, Esq., Vice President and Assistant.

DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS Physician Labeling Rule Lisa Soule, M.D.

How to Apply FDA Rules to the Emerging Social Media Environment National Pharma Audio Conference May 20, 2009.

The Role of the FDA Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration October 26, 2004.

Promotion & Enforcement FDA’s Social Media Guidance.

OPDP Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration September.

Type 2 diabetes treatment: Old and New Emily Szmuilowicz, MD, MS Assistant Professor of Medicine Division of Endocrinology Northwestern University.

Prof. Moustafa M. Mohamed Vice dean Dr. Safa Ahmed El-askary Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation.

FDA Science Board CDER Drug Safety Update November 6, 2005 Rockville, MD Steven Galson, MD, MPH Director, Center for Drug Evaluation and Research Food.

General Regulatory Issues in the Development of Drugs Intended for Treatment of Chronic Illness Sharon Hertz, M.D. Medical Officer Division of Anesthetic,

Pharmacogenetics.

RESTICTED DRUGS Risk Evaluation and Mitigation Strategies--REMS

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

October 28, F OOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 (FDAAA) and Risk Evaluation and Mitigation Strategies (REMS) Presented to the Ninth.

1 One Year Post Exclusivity Adverse Event Review: Sumatriptan Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer.

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) Question 1: Messages about Risk A. Based.

Promotion of Prescription Drugs and Biologics Thomas O. Henteleff Kleinfeld, Kaplan and Becker LLP Company logo here.

FDA Regulation of Pharmaceutical Marketing Tom Casola Executive Director Commercial Operations Merck & Co., Inc.

1 Risk Management Considerations for Romiplostim Suzanne Berkman, PharmD Senior Risk Management Analyst Division of Risk Management Office of Surveillance.

OSHA Office of Training and Education 1 Hazard Communication.

Prepared by: Imon Rahman Lecturer Department of Pharmacy BRAC University.

Addressing Tobacco Use in Mental Health Settings Pharmacotherapy Materials Prepared By: Center for a Tobacco-Free Finger Lakes University of Rochester.

Given the progress that continues to be made in society’s battle against disease, patients are seeking more information about medical problems and potential.

1 One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin Pediatric Advisory Committee Meeting February 14, 2005 Hari Cheryl Sachs, MD, FAAP.

27 June 2000Victor F. C. Raczkowski, M.D.1 Risk-Management Options Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory Committee 27 June.

Denis G. Patterson, DO ECHO Project April 20, 2016 CDC Guidelines for Prescribing Opioids for Chronic Pain.

FDA Update on Advertising and Promotion of Prescription Drugs Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications.

Focus On Nonvitamin/ Nonmineral Supplements. Copyright 2010, John Wiley & Sons, Inc. Types of Dietary Supplements.

Efficacy and Safety of Medicines

What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection NJPIRG Law & Policy Center MAY 2006.

Smoking Cessation, Suicide and Varenicline: A Systematic Review

Empagliflozin (Jardiance®)

Black Box Warning What You Need To Know.

Implementation Considerations

AndroGel Package Label Changes

Presentation transcript:

Regulation of Promotion of Prescription Drugs Thomas W. Abrams, R.Ph., MBA Division of Drug Marketing, Advertising, and Communications Food and Drug Administration November 13, 2002

Goal and Objectives n Goal –To protect and promote public health n Objectives –Ensure that RX drug promotion is not false or misleading –Ensure that complete picture of drug is conveyed –Get more useful information about drugs and diseases to the American public

Mechanisms for Meeting Objectives n Comprehensive surveillance and enforcement program n Voluntary compliance –Guidance documents –Request for comments –Educational efforts

Advice to Industry n Provide comments on promotional materials (VOLUNTARY) –Launches –Direct-to-consumer (DTC) broadcast ads –Other materials n Guidance Documents n Educational efforts –Outreach –Website

Enforcement Options n Untitled letters (notice of violation or NOV) n Warning Letters n Injunctions/consent decrees n Seizures n Criminal actions

Hydrea/Droxia Warning Letter n Promotion of unapproved use –treatment of HIV n Failure to disclose safety information –study results of higher toxicity and two fatal cases of pancreatitis

Avandia Warning Letter - Background n Labeling was revised to include warning about use with insulin –The use of Avandia in combination therapy with insulin is not indicated –In clinical studies, an increased incidence of heart failure and other cardiovascular adverse events were seen in patients on Avandia and insulin combination therapy compared to insulin plus placebo

Avandia Warning Letter n Sales rep stated that there had been no changes to the PI concerning risk of CHF with Avandia n Another sales rep also stated that there had been no changes to the Avandia PI and stated that he was unaware of any new risk information concerning CHF

Viread n Commercial exhibit hall n Minimized boxed warning –Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals

Viread n “No toxicities” n “Extremely safe” n “Extremely well-tolerated” n The boxed warning is a “product class warning, and there are no problems but it was put into the PI as a ‘wait and see’ warning”

Accutane n Bolded Warning - Psychiatric Disorders: Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts. Discontinuation of Accutane may be insufficient; further evaluation may be necessary.

Accutane n “We don’t feel it’s an issue.” n “News has hyped it up.” n “Like any drug used in patients with depression, such as penicillin, it could bring it out.”

Thalomid Warning Letter n Violative Promotion by Company Representatives n Representatives promoted off label uses Use for various types of cancer Use for cancer patients’ “weight loss” Use for feeling of “general well being”

Xanodyne Warning Letter n Multiple Products –Methotrexate –Leucovorin –Amicar n Omission of risk information n Omission of material facts - indications

Xanodyne Warning Letter n Methotrexate –Claims such as “has its maximum effect on cells … such as cancer cells –Omission of risks such as Boxed warning regarding possibility of serious toxic, fatal reactions Deaths have been reported with the use of methotrexate in the treatment of malignancy …. Patients should be monitored for bone marrow, liver, lung, and kidney toxicities

Tamiflu n DTC radio broadcast advertisement n Omission of material facts –indicated … who have been asymptomatic for no more than two days –no evidence that drug will convey any benefit if taken later in the illness n “So when I felt the flu symptoms again, I took Tamiflu”

Tamiflu n Overstatement of Efficacy –“I felt better so soon that I didn’t miss a single day of training” –“with the first dose things started to look up” n 1.3 day reduction to flu symptom improvement vs placebo

Imitrex n DTC television advertisement n Unsubstantiated comparative claim –comparison to other prescription drugs n Video: Migraine suffer looking at amber rx bottle n Voiceover: “…a migraine my medicine just dulled the pain. So I talked to my doctor. He prescribed Imitrex. Imitrex targets your total migraine.”